Import Alert 60-02

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 60-02

Published Date: 12/14/2012

Type: DWPE with Surveillance

Import Alert Name:

"Detention of Anabolic Steroid Prescription Drugs"

Reason for Alert:

Anabolic steroids may be safely administered under the care of a physician for replacement therapy in patients with hormone deficiency in males, and for certain gynecologic conditions and breast cancer in women. There are reports that the steroids are being used outside of their approved indications by athletes (without disease) to increase their body size.

FDA is working with the Department of Justice, the Federal Bureau of Investigation and U.S. Customs Service to investigate reports that these steroids are being brought into this country and are being sold illegally. Reports of misuse and illegal sale of anabolic steroids are also being investigated.

Some common names of steroids that may be misused are listed in this alert. While the list represents common brand names of finished anabolics, we are also interested in receiving reports of attempted entries of bulk anabolics under this Alert.

Notify the contact below before acting to detain any entries of human or veterinary anabolic steroids. You will be advised if it is appropriate to raise the following charge at that time.

If appropriate, charge:

Human: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug, within the meaning of Section 201(p), without an effective new drug application as required by Section 505(a) and appears to be misbranded within the meaning of Section 502."

OASIS charge code - UNAPPROVED OR

Veterinary: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new animal drug, within the meaning of Section 201(w), without an effective new animal drug application as required by Section 501(a)(5) and appears to be misbranded within the meaning of Section 502."